Mayo Clinic leads FDA trial of next-generation sutureless aortic valve replacement technology

Since the introduction of surgical aortic valve replacement more than 50 years ago, innovations in valve design and surgical technique, as well as the advent of transcatheter valve technology, have provided an array of new therapeutic options for patients with aortic valve disease. Due to the fact that transcatheter aortic valve implantation — also referred to as transcatheter aortic valve replacement (TAVI or TAVR) — relies upon the insertion of a new valve within a diseased native aortic valve, debate over whether debris embolization and stroke risks are elevated persists in the cardiac care community.

While the equivalence of TAVR to surgical aortic valve replacement in high-risk surgical patients has been demonstrated in the PARTNER Trial (Edwards SAPIEN valve), whether TAVR is appropriate for lower risk patients who have very good outcomes after traditional aortic valve replacement will remain less clear until the results of the PARTNER II (Edwards SAPIEN XT valve) and SURTAVI (Medtronic CoreValve) trials become available.

In the interim, patients who are candidates for traditional surgical aortic valve replacement may benefit from a shortening of the time spent supported by the heart and lung bypass machine and performance of the operation through smaller and presumably better tolerated incisions.

The new Sorin Perceval valve has offered such an alternative to patients in Europe since 2007 (CE approval 2011) and more recently in Canada. The Perceval valve-insertion strategy is very similar to traditional aortic valve replacement, allowing removal of native aortic disease followed by insertion of a new valve prosthesis, freeing patients of valve calcium burden prior to insertion of a new pericardial aortic valve device. All this is performed without the need for sutures, thereby shortening operative times, decreasing certain complications, and allowing minimally invasive approaches.

Mayo Clinic in Rochester, Minn., is leading the Perceval multicenter clinical trial nationally and also is a participating site. The trial received investigational device exemption (IDE) approval from the Food and Drug Administration. The objectives of the trial are to establish safety and clinical efficacy in comparison to historical controls.

Inclusion criteria

  • Age ≥ 18 years
  • Aortic valve stenosis or combination stenosis/regurgitant of native or prosthetic valve
  • Willing to travel for postoperative study follow-up
  • The ratio of the sinotubular junction divided by the aortic annulus diameter (assessed by transthoracic or transesophageal echocardiogram) is < 1.3

Exclusion criteria

  • Pre-existing prosthesis or annuloplasty ring in mitral, pulmonic or tricuspid valve
  • Repair or replacement of additional valves required
  • Active endocarditis or myocarditis
  • Aortic root enlargement
  • Ascending aortic dissection or dilation
  • Unable to give informed consent
  • Substance abuse
  • Concomitant life-limiting disease (prognosis < 1 year)
  • Hypersensitivity to nickel alloys
  • Renal dialysis
  • Hyperparathyroidism
  • Unresolved acute neurological or cardiac event within past 30 days

To enroll a patient

For additional information about the trial or enrolling a patient, please contact: